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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT HF; No Match
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ABBOTT GALLANT HF; No Match Back to Search Results
Model Number CDHFA500Q
Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2023
Event Type  malfunction  
Event Description
During a clinic follow-up, the device was found to be in backup vvi (bvvi) mode resulting in a loss of high voltage therapy.The cause of the bvvi was found to be off-label mri exposure.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was in stable condition.
 
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Brand Name
GALLANT HF
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18144559
MDR Text Key328206418
Report Number2017865-2023-52561
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032010
UDI-Public05415067032010
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Model NumberCDHFA500Q
Device Lot NumberP000139672
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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